Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". GE Medical Systems, LLC Laura Turner Regulatory Affairs Leader 3000 N. Grandview Blvd. WAUKESHA, WI 53188 July 26, 2019 #### Re: K191777 Trade/Device Name: Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: July 1, 2019 Received: July 2, 2019 Dear Laura Turner: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191777 Device Name Revolution CT #### Indications for Use (Describe) The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy. If the spectral imaging option is included on the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures. GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus nonuric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The logo is colored in a light blue hue. The logo is simple and recognizable. # GE Healthcare 510(k) Premarket Notification Submission for Revolution CT Family # 510(k) SUMMARY OF SAFETY AND EFFECTIVNESS This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h): | Date: | July 1, 2019 | |---------------------|----------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems, LLC<br>3000 North Grandview Blvd<br>Waukesha, WI 53188 | | Primary Contact: | Laura Turner<br>Regulatory Affairs Leader<br>GE Healthcare<br>Phone 262-548-4588<br>Email: laura.turner@ge.com | | Secondary Contacts: | Helen Peng<br>Regulatory Affairs Director | GE Healthcare Tel: 262-424-8222 Email: hong.penq@med.ge.com > John Jaeckle Chief Regulatory Affairs Strategist GE Healthcare Tel: 262-424-9547 Email: john.jaeckle@med.ge.com ## PRODUCT IDENTIFICTION | Device Name: | Revolution CT, Revolution CT ES, Revolution CT with Apex edition,<br>Revolution Apex | |------------------------------------|--------------------------------------------------------------------------------------| | Regulation number/<br>Product Code | 21 CFR 892.1750 Computed tomography x-ray system /<br>JAK | Device Classification Class II {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The frame has small, teardrop-shaped embellishments around its perimeter, giving it a slightly decorative appearance. The logo is rendered in a blue color. ### Predicate Device Information: | Device Name | Revolution CT | |------------------------------------|----------------------------------------------------------------------------| | Manufacturer | GE Medical System, LLC.<br>3000 North Grandview Blvd<br>Waukesha, WI 53188 | | 510(k) number | K163213 cleared on December 16, 2016 | | Requlation number<br>/product Code | 21 CFR 892.1750 Computed tomography x-ray system /<br>JAK | #### Device Description: Revolution CT Family with SmartScout The Revolution CT family of products including Revolution CT. Revolution CT ES and Revolution Apex are multi-slice CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. The Revolution CT ES has 128 detector rows with 80mm coverage while the Revolution CT and Revolution Apex have 256 detector rows with 160mm detector coverage. GE has modified the cleared Revolution CT (K163213) within our design controls to include the SmartScout Option to offer optimized thermal management and improved workflow. The SmartScout mode, if selected by the user, allows for performance of tube warmups during patient scout scanning, eliminating user intervention and wait times for tube warmup. It quides the user to the optimal scout scanning parameters, in order to optimize image quality and dose during patient scanning. The user will still have access to the Regular Scout mode where all traditional routine scout technique settings can be accessed and manually prescribed, such as kV, mA, and cradle speed. SmartScout is an added capability and does not remove access to Regular scout mode. Qualitative and quantitative phantom studies demonstrate that the SmartScout delivers the similar CT Scout image quality at the similar size-appropriate dose levels (CTDIvol) compared to reqular Scout scan. The SmartScout option will be offered on the Revolution Apex system configuration initially and can be ported to Revolution CT and Revolution CT ES in the future. This modified system has the same intended use and indications for use as its predicate device. The modified system employs the same basic fundamental operating principles as the existing marketed product Revolution CT, and is of comparable type and substantially equivalent to its predicate device. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script font in the center. There are three white teardrop shapes around the letters, one at the top and one on each side. The logo is simple and recognizable, and it is associated with a well-known and established company. #### Intended Use The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. #### Indications for Use The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different anales. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, quiding, and monitoring therapy. If the spectral imaging option is included on the system, the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures. GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition. ## Technology of SmartScout {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The letters and the border are both a light blue color. There are three white, teardrop-shaped elements evenly spaced around the outside of the circle. The SmartScout feature involves hardware and software changes. The change to implement SmartScout involves minor changes to the source collimator, and corresponding software modifications to manage the new scout scan mode as well as managing the tube thermal conditions, while also meeting a user-selected patient CTDIvol for the scout. SmartScout accomplishes this dual concurrent goal in addition to delivering equivalent performance to Regular scout in terms of sizing of the patient anatomy for the purposes of AEC and diagnostic scan range prescription. The workflow for SmartScout is designed to be as similar as possible to that of the Reqular scout mode. The need for a tube warmup is dependent upon on the system-specific patient throughput and prior scanning history. The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device: | Specification/ | Predicate Device | Proposed Device | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | Revolution CT (K163213) | | | Patient Population | The system is indicated for head,<br>whole body, cardiac, and<br>vascular X-ray Computed<br>Tomography applications for<br>patients of all ages | Same | | Contraindications | None | Same | | Source Collimator | Wolverine Collimator<br>• 160 mm Aperture<br>• 5 beam locations (small,<br>medium, large,<br>Calibration Filter (air),<br>blocked) | Wolverine 2 Collimator<br>• 160 mm Aperture<br>• 6 beam locations (small,<br>medium, large, large +<br>copper, Calibration Filter<br>(air), blocked) | | Scan Mode | Scout<br>Axial<br>Helical<br>Cine<br>Cardiac<br>Gated<br>High Definition<br>Fluoro (axial)<br>GSI | Scout<br>Axial<br>Helical<br>Cine<br>Cardiac<br>Gated<br>High Definition<br>Fluoro (axial)<br>GSI<br>SmartScout | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The color of the logo is a light blue. The logo is simple and recognizable. # Determination of Substantial Equivalence The Revolution CT Family with SmartScout option has completed testing and is in compliance with IEC 60601-1 Ed. 3 and its associated collateral and particular standards, 21CFR Subchapter J. and NEMA XR-25, XR-26, XR-28 and XR-29. The proposed device has successfully completed all testing per our quality system as well as comparison testing to the predicate device. It was designed and is manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system: - Risk Analysis - · Required Reviews - · Design Reviews - Testing on unit level (Module verification) - · Integration testing (System verification) - · Performance testing (Verification) - · Safety testing (Verification) - · Simulated use testing (Validation) GE believes the Revolution CT Family system is of comparable type and substantially equivalent to our currently marketed system Revolution CT (K163213). The substantial equivalence was also based on software documentation for a "Moderate" level of concern device. # Summary of Additional Testing In addition to the verification and validation testing successfully completed as required by GE Healthcare's quality system, additional engineering (non-Clinical testing) was performed to provide the requisite data to substantiate performance claims, the revised indications, and ultimately substantial equivalence. # Non-Clinical Testing The performance evaluation testing used a variety of phantoms representing head and body to provide technical substantiation of the SmartScout performance on the Revolution Apex. Various mathematical and statistical analyses were performed to demonstrate that each performance item was successfully verified and substantiated for data acquisition and optimized image generation. The evaluation also included pediatric phantom evaluation. # Clinical Testing The Revolution CT family with SmartScout can be fully tested on the engineering bench thus no additional clinical testing was required. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are decorative swirls or flourishes around the outer edge of the circle, giving it a classic or vintage appearance. ## Substantial Equivalence Conclusion: Based on the conformance to standards, development under our quality system, and the engineering testing provided, GE Medical Systems believes that the Revolution CT with SmartScout option is as safe and effective, and performs in a substantially equivalent manner to the predicate device Revolution CT (K163213).